NCT07337512

Moringa Oleifera and Phoenix Dactylifera L. Effects on Cortisol and Breast Milk in Postpartum Depression

Moringa Oleifera and Phoenix Dactylifera L. Effects on Cortisol and Breast Milk in Postpartum Depression: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 363 (actual)
• Sponsor: Melania Asi · Academic / Other
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

Postpartum depression affects 10-20% of new mothers globally, potentially disrupting breast milk production. This study aimed to provide valuable insights into effective interventions to improve the health and well-being of Postpartum Mothers with depression. This study used a randomized controlled trial design with three groups: intervention 1 (dates), intervention 2 (Moringa oleifera), and a control group. A total of 363 postpartum mothers participated, and data were collected through salivary cortisol levels (ELISA) and Beck Depression Inventory (BDI) scores to measure depression levels and breast milk production (ACIS AC-15X digital scale and Crown electric breast pump) before and after the intervention for 28 days. Data analysis was performed using paired sample t-test and the independent t-test.

Conditions

• Postpartum Depression (PPD)

Interventions

Type	Name	Description
DRUG	Phoenix dactylifera L	The intervention method in this study used Phoenix dactylifera L. (dates) as the main ingredient with a standardized dose of 120 grams per day per participant, divided into three 40-gram portions over a 28-day period. The dates used were food-grade with a Certificate of Analysis (CoA) certification from a trusted supplier to ensure quality and safety of consumption. Measurement instrumentation included a digital scale with an accuracy of ±0.1 grams for daily portions, an analytical balance for high-precision measurements, and a measuring cup to ensure portion consistency. The storage and distribution system was designed using food-grade airtight containers, individual plastic bags, a cooler box for transportation, and silica gel packets for humidity control, equipped with a waterproof labeling system. Documentation and monitoring were carried out using a food diary form, a 28-day intervention calendar, and a digital camera for visual documentation.
DRUG	Moringa oleifera	Moringa oleifera: The intervention method in this study used Moringa oleifera capsules as the primary therapeutic agent at a standard dose of 1000 mg per day per participant, administered in two divided doses of 500 mg each (morning and evening) for a 28-day period. The Moringa oleifera capsules used were pharmaceutical-grade capsules with appropriate quality certification from a verified supplier to ensure purity and safety for human consumption. Measurement instruments included a precision analytical balance with an accuracy of ±0.1 mg for capsule weight verification, an automatic capsule counter for dose consistency, and a calibrated measuring device to ensure uniform distribution. The storage and distribution system was implemented using pharmaceutical-grade amber glass containers to protect from light degradation, individual blister packs for daily doses, temperature-controlled storage units, and desiccant packs for humidity control, equipped with a labeling system that indicated
OTHER	Placebo: consumed food three times a day	consumed food three times a day: Participants received no additional intervention and only consumed food three times a day for 28 days, serving as a baseline to compare the effects of the intervention.

Timeline

• Start date: 2024-05-19
• Primary completion: 2024-11-19
• Completion: 2024-11-19
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: Indonesia